FDA.reportPublic FDA data

Carvedilol Phosphate

Product NDC
60505-4715
11-digit product format
605054715
Labeler code
60505
Product ID
60505-4715_69bbb7a7-deed-4c83-83ed-26b0c50beb1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carvedilol phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp.
Application
NDA022012
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-11-01
Marketing end
0000-00-00
Substance
CARVEDILOL PHOSPHATE
Active strength
40 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60505-4715-32023-01-30C16284748780-1f386c64a-1f6a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Carvedilol Phosphate extended-release capsules safely and effectively. See full prescribing information for Carvedilol Phosphate extended-release capsules. Carvedilol Phosphate extended-release capsules for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-4715-3Carvedilol Phosphate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4715-3EA - Each60505-4715eda3228d-286f-4f69-bf85-a18087d60cf112020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4715CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]12Legacy NDC, 1 package rows20210916_bcfe4b84-500e-4b93-ba20-aa7c4297b0ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSNbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12
860516carvedilol phosphate 20 MG 24HR Extended Release Oral CapsulePSNbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12
860522carvedilol phosphate 40 MG 24HR Extended Release Oral CapsulePSNbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSNbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCDbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12
86051624 HR carvedilol phosphate 20 MG Extended Release Oral CapsuleSCDbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12
86052224 HR carvedilol phosphate 40 MG Extended Release Oral CapsuleSCDbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCDbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSYbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12
860516carvedilol phosphate 20 MG 24 HR Extended Release Oral CapsuleSYbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12
860522carvedilol phosphate 40 MG 24 HR Extended Release Oral CapsuleSYbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSYbcfe4b84-500e-4b93-ba20-aa7c4297b0ae12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-4715-36050547150330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-4715-3) 2019-11-010000-00-00NoNoCurrent